Finding blood test reference intervals for transgender people on hormone therapy
Reference Intervals for 27 Routine Chemistry and Immunoassay Tests in Transgender Adults on Stable Hormone Therapy
This study is trying to find the right blood test ranges for transgender and non-binary people on hormone therapy to help doctors understand their test results better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04478760 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish reference intervals for common blood tests specifically for transgender and non-binary individuals undergoing hormone therapy. By analyzing blood test results from participants who have been on hormone therapy for at least 12 months, the study seeks to provide accurate reference values that can help healthcare providers interpret test results more effectively. This is crucial as traditional reference intervals may not apply to transgender individuals due to hormonal changes. The study will focus on those receiving routine monitoring at a clinic to ensure comprehensive data collection.
Who should consider this trial
Good fit: Ideal candidates for this study are transgender or non-binary individuals aged 18 and older who have been on hormone therapy for at least 12 months.
Not a fit: Patients who may not benefit from this study include those with severe chronic diseases or conditions that could skew blood test results.
Why it matters
Potential benefit: If successful, this study could lead to more accurate health assessments and faster disease identification for transgender patients.
How similar studies have performed: While there is limited data on similar studies, establishing tailored reference intervals for specific populations is a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Transgender or nonbinary people. * Aged 18 or older. * Taking testosterone or oestrogen therapy. * For 12 months or more. * Having routine hormone therapy monitoring at the clinic. Exclusion Criteria: * Unable to give informed consent (including participants who cannot communicate in English). * History of chronic liver disease, chronic kidney disease, diabetes, or severe cardiovascular disease (including myocardial infection, deep vein thrombosis, stroke and pulmonary embolism). * Blood test results that indicate severe disease. * Pregnant or within one year after childbirth. * Other conditions which could put participants at risk by participating, or which could influence the results of the study.
Where this trial is running
London
- Caldecot Centre, King's College Hospital, 15-22 Caldecot Road — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Michael Brady, FRCP — King's College Hospital NHS Trust
- Study coordinator: Devon Buchanan, MSc
- Email: devon.buchanan@nhs.net
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.